WO2018119380A3 - Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties - Google Patents

Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties Download PDF

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Publication number
WO2018119380A3
WO2018119380A3 PCT/US2017/068154 US2017068154W WO2018119380A3 WO 2018119380 A3 WO2018119380 A3 WO 2018119380A3 US 2017068154 W US2017068154 W US 2017068154W WO 2018119380 A3 WO2018119380 A3 WO 2018119380A3
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WO
WIPO (PCT)
Prior art keywords
residue
design
substitution
heavy chain
therapeutic immunoglobulin
Prior art date
Application number
PCT/US2017/068154
Other languages
French (fr)
Other versions
WO2018119380A2 (en
Inventor
Yueming Qian
Zhengjian Li
Xuankuo Xu
Zhijun TAN
Chao Huang
Zhiqiang Chen
Original Assignee
Bristol-Myers Squibb Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bristol-Myers Squibb Company filed Critical Bristol-Myers Squibb Company
Priority to KR1020197021021A priority Critical patent/KR102702612B1/en
Priority to JP2019534111A priority patent/JP7062669B2/en
Priority to CN201780087166.3A priority patent/CN110461869B/en
Priority to US16/471,708 priority patent/US11542337B2/en
Priority to EP17854212.2A priority patent/EP3559029A2/en
Priority to KR1020247029257A priority patent/KR20240134400A/en
Priority to CN202410149806.0A priority patent/CN118047864A/en
Publication of WO2018119380A2 publication Critical patent/WO2018119380A2/en
Publication of WO2018119380A3 publication Critical patent/WO2018119380A3/en
Priority to JP2022069326A priority patent/JP7432650B2/en

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2827—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62—DNA sequences coding for fusion proteins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Plant Pathology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)

Abstract

In certain embodiments, the disclosure provides an IgG4 antibody comprising a heavy chain and a light chain, wherein the heavy chain comprises: (a) a modified IgG4 CH1 region having a substitution of the lysine residue at position 196; or (b) a modified IgG4 hinge region having a substitution of the serine residue at position 217, the glycine residue at position 220, the proline residue at position 224 or the proline residue at position 225. Preferably, the IgG4 antibody further comprises a substitution of the serine residue at position 228 in the heavy chain hinge region.
PCT/US2017/068154 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties WO2018119380A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
KR1020197021021A KR102702612B1 (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin G4 for improved bioanalytical and bioprocessing properties
JP2019534111A JP7062669B2 (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin G4 for improved bioanalytic and bioprocessing properties
CN201780087166.3A CN110461869B (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin G4 for improved bioassay and bioprocessing characteristics
US16/471,708 US11542337B2 (en) 2016-12-23 2017-12-22 Therapeutic immunoglobulin G4 for improved bioanalytical and bioprocessing properties
EP17854212.2A EP3559029A2 (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties
KR1020247029257A KR20240134400A (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties
CN202410149806.0A CN118047864A (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin G4 for improved bioassay and bioprocessing characteristics
JP2022069326A JP7432650B2 (en) 2016-12-23 2022-04-20 Design of therapeutic immunoglobulin G4 for improved bioanalytical and bioprocessing properties

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662438684P 2016-12-23 2016-12-23
US62/438,684 2016-12-23

Publications (2)

Publication Number Publication Date
WO2018119380A2 WO2018119380A2 (en) 2018-06-28
WO2018119380A3 true WO2018119380A3 (en) 2018-08-30

Family

ID=61750479

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/068154 WO2018119380A2 (en) 2016-12-23 2017-12-22 Design of therapeutic immunoglobulin g4 for improved bioanalytical and bioprocessing properties

Country Status (6)

Country Link
US (1) US11542337B2 (en)
EP (1) EP3559029A2 (en)
JP (2) JP7062669B2 (en)
KR (2) KR102702612B1 (en)
CN (2) CN110461869B (en)
WO (1) WO2018119380A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220052300A (en) * 2020-10-20 2022-04-27 전남대학교산학협력단 Flagellin fusion protein and uses thereof
US20230303719A1 (en) 2022-03-03 2023-09-28 Yale University Humanized 3e10 antibodies, variants, and antigen binding fragments thereof
KR20230148956A (en) * 2022-04-19 2023-10-26 전남대학교산학협력단 Composition for treating liver disease or metabolic syndrome comprising fusion protein of flagellin and immunoglobulin Fc region
KR20230148959A (en) * 2022-04-19 2023-10-26 전남대학교산학협력단 Composition for treating colitis comprising fusion protein of flagellin and immunoglobulin Fc region

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WO2016026943A1 (en) * 2014-08-20 2016-02-25 Argen-X N.V Asymmetric multispecific antibodies

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Also Published As

Publication number Publication date
JP2022109960A (en) 2022-07-28
KR102702612B1 (en) 2024-09-06
JP2020504608A (en) 2020-02-13
JP7062669B2 (en) 2022-05-06
EP3559029A2 (en) 2019-10-30
US11542337B2 (en) 2023-01-03
CN110461869B (en) 2024-02-06
WO2018119380A2 (en) 2018-06-28
CN118047864A (en) 2024-05-17
KR20240134400A (en) 2024-09-09
KR20190095946A (en) 2019-08-16
US20200109208A1 (en) 2020-04-09
JP7432650B2 (en) 2024-02-16
CN110461869A (en) 2019-11-15

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